INTRAOSSEOUS-NEEDLE STABILIZER AND METHODS

Abstract

Stabilizers for intraosseous devices, such as, for example, stabilizers that may be coupled to an intraosseous device (e.g., a device including an intraosseous needle) while a portion of the device extends into a patient's bone and/or while the device is coupled to a fluid source (e.g., IV bag, syringe, etc.).

Claims

1. A stabilizer for an intraosseous device, the stabilizer comprising: a first stabilizer member including a first coupling surface and a first connection portion; a second stabilizer member including a second coupling surface and a second connection portion; where the first the first connection portion of the first stabilizer member is releasably engageable with the second connection portion of the second stabilizer member; where the first and second coupling surfaces cooperate to define an opening for receiving a portion of the intraosseous device when the first connection portion engages the second connection portion, the opening extending from a proximal end of the stabilizer to a distal end of the stabilizer; and where the stabilizer is operable to keep the intraosseous device in a stable position relative to the patient when the first connection portion of the first stabilizer member engages the second connection portion of the second stabilizer member.

2. The stabilizer of claim 1, wherein a portion of the opening has a longitudinal axis disposed at a non-zero degree angle relative to a plane of a proximal surface of the first stabilizer member and a plane of a proximal surface of the second stabilizer member.

3. The stabilizer of claim of claim 2, wherein the longitudinal axis of the opening is perpendicular to the plane of the proximal surface of the first stabilizer member and the plane of the proximal surface of the second stabilizer member.

4. The stabilizer of claim 2, where the first stabilizer member comprises a first sidewall and a first tab coupled to the first sidewall, and the second stabilizer member comprises a second sidewall and a second tab coupled to the second sidewall.

5. The stabilizer of claim 2, further comprising a first tab extending from the first stabilizer member, and a second tab extending from the second stabilizer member.

6. The stabilizer of claim 5, further comprising an adhesive layer coupled to at least one of the first and second tabs for adhering the stabilizer to the skin of the patient.

7. The stabilizer of claim 5, wherein the first tab comprises a first double-sided adhesive layer having an upper side coupled to a lower surface of the first stabilizer member, and the second tab comprises a second double-sided adhesive layer having an upper side coupled to a lower surface of the second stabilizer member.

8. The stabilizer of claim 7, wherein the first tab further comprises a first single-sided adhesive layer having a lower side coupled to an upper surface of the first stabilizer member and to a portion of the upper side of the first double-sided adhesive layer that is not coupled to the lower surface of the first stabilizer member; and the second tab further comprises a second single-sided adhesive layer having a lower side coupled to an upper surface of the second stabilizer member and to a portion of the upper side of the second double-sided adhesive layer that is not coupled to the lower surface of the second stabilizer member.

9. The stabilizer of claim 8, wherein the first tab further comprises a first liner layer coupled to a lower side of the first double-sided adhesive layer, the first liner layer configured to be removable from the lower side of first double-sided adhesive layer such that the lower side of the first double-sided adhesive layer can be adhered to the skin of the patient; and the second tab further comprises a second liner layer coupled to a lower side of the second double-sided adhesive layer, the second liner layer configured to be removable from the lower side of second double-sided adhesive layer such that the lower side of the second double-sided adhesive layer can be adhered to the skin of the patient.

10. The stabilizer of claim 9, wherein the first liner layer includes a first tab portion extending beyond a peripheral edge of the first double-sided adhesive layer, and the second liner layer includes a second tab portion extending beyond a peripheral edge of the second double-sided adhesive layer.

11. The stabilizer of claim 5, wherein the first and second tabs are flexible.

12. The stabilizer of claim 2, wherein the first and second stabilizer members include a respective outer portion for gripping by a user.

13. The stabilizer of claim 12, wherein the outer portion includes an arcuate shape.

14. The stabilizer of claim 12, wherein the outer portion includes a square shape.

15. The stabilizer of claim 12, wherein the outer portion includes an expanded or indented portion.

16. The stabilizer of claim 2, wherein the first connection portion of the first stabilizer member is configured as a male connection portion, and the second connection portion of the second stabilizer member is configured as a female connection portion, such that the female connection portion of the second stabilizer member is configured to receive the male connection portion of the first stabilizer member.

17. The stabilizer of claim 16, wherein the female connection portion comprises a ledge, and the male connection portion of the first stabilizer member is configured to contact the ledge of the second stabilizer member to resist separation of the first and second stabilizer members.

18. The stabilizer of claim 17, wherein the male connection portion of the first stabilizer member is configured to move past the ledge of the second stabilizer member and mechanically resist separation of the first and second stabilizer members.

19. The stabilizer of claim 2, wherein the opening is configured to receive the portion of the intraosseous device in a first position relative to the proximal surface of the first stabilizer member and the proximal surface of the second stabilizer member.

20. The stabilizer of claim 19, wherein the opening is further configured to receive the portion of the intraosseous device in a second position relative to the proximal surface of the first stabilizer member and the proximal surface of the second stabilizer member.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The following drawings illustrate by way of example and not limitation. For the sake of brevity and clarity, every feature of a given structure is not always labeled in every figure in which that structure appears. Identical reference numbers do not necessarily indicate an identical structure. Rather, the same reference number may be used to indicate a similar feature or a feature with similar functionality, as may non-identical reference numbers. The figures are drawn to scale (unless otherwise noted), meaning the sizes of the depicted elements are accurate relative to each other for at least the embodiment depicted in the figures.

[0017] FIG. 1 depicts a perspective view of one embodiment of the present stabilizers which includes two stabilizer members and two flexible tabs.

[0018] FIG. 2 depicts a top view of the stabilizer of FIG. 1.

[0019] FIG. 3 depicts a perspective cross-sectional view of the stabilizer of FIG. 1 taken along the line 3-3 of FIG. 1.

[0020] FIG. 4 depicts a side view of a member of the stabilizer of FIG. 1 shown with an intraosseous device in a first position relative to the stabilizer.

[0021] FIG. 5 depicts a side view of a member of the stabilizer of FIG. 1 shown with an intraosseous device in a second position relative to the stabilizer.

[0022] FIG. 6 depicts a perspective view of a member of the stabilizer of FIG. 1.

[0023] FIGS. 7A-7C depicts various views of a member and a flexible tab of the stabilizer of FIG. 1.

[0024] FIGS. 8A-8G depicts various views of the member of FIG. 6.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0025] The term coupled is defined as connected, although not necessarily directly, and not necessarily mechanically; two items that are coupled may be unitary with each other. The terms a and an are defined as one or more unless this disclosure explicitly requires otherwise. The term substantially is defined as largely but not necessarily wholly what is specified (and includes what is specified; e.g., substantially 90 degrees includes 90 degrees and substantially parallel includes parallel), as understood by a person of ordinary skill in the art.

[0026] The terms comprise (and any form of comprise, e.g., comprises and comprising), have (and any form of have, e.g., has and having), include (and any form of include, e.g., includes and including) and contain (and any form of contain, e.g., contains and containing) are open-ended linking verbs. As a result, a device or kit that comprises, has, includes or contains one or more elements possesses those one or more elements, but is not limited to possessing only those elements. Likewise, a method that comprises, has, includes or contains one or more steps possesses those one or more steps, but is not limited to possessing only those one or more steps.

[0027] Further, a device or structure that is configured in a certain way is configured in at least that way, but it can also be configured in other ways than those specifically described. As used in this disclosure, a part or component that is unitary with another part or component means that the parts are of a physically continuous piece of material (e.g., are not physically separate from one another). For example, two of the present members may be of unitary construction if molded or otherwise formed as a single piece of material (e.g., with a flexible piece of material joining the two members in such a way that their connection portions may fixedly couple the two members together, as described in more detail below, and that also maintains a flexible connection between the two members if their connection portions are not coupled together).

[0028] Some embodiments of the present stabilizers are configured to couple an intraosseous (sometimes referred to as an interosseous) device to various bones and/or through various sites on a patient (e.g., arm, leg, sternum, shoulder. Examples of such intraosseous devices include the EZ-IO line of products offered by Vidacare Corporation, San Antonio, Tex., USA; and may include a hub with a cannula and/or an intraosseous needle (the intraosseous needle may be removable after insertion of the device such that a portion of the device extends into a bone of a patent).

[0029] Referring now to the drawings, and more particularly to FIGS. 1-5, shown therein and designated by the reference numeral 10 is an embodiment of the present stabilizers. FIG. 1 depicts a perspective view of stabilizers 10 that includes two stabilizer members 14a, 14b, and two flexible tabs 18a, 18b. FIG. 2 depicts a top view of stabilizer 10. FIG. 3 depicts a perspective cross-sectional view of stabilizer 10 taken along the line 3-3 of FIG. 1. FIG. 4 depicts a side view of member 14a of stabilizer 10 shown with an intraosseous device 5 in a first position relative to the stabilizer. FIG. 5 depicts a side view of member 14a of stabilizer 10 shown with intraosseous device 5 in a second position relative to the stabilizer.

[0030] In the embodiment shown, members 14a and 14b are configured to be coupled together (and are shown coupled together) such that members 14a and 14b cooperate to encircle intraosseous device 5 (e.g., such that neither member individually encircles device 5) to resist movement of intraosseous device 5 relative to members 14a and 14b. In some embodiments, stabilizer 10 comprises one or more flexible tabs (18a, 18b) each coupled to at least one of the members (14a, 14b) and comprising an adhesive layer (not shown) configured to be coupled to skin of a patient. For example, in the embodiment shown, stabilizer 10 comprises two flexible tabs 18a and 18b each coupled to a different one of members 14a and 14b, respectively. Once the flexible tabs have been coupled to skin, the stabilizer is designed to keep the intraosseous device to which it has been coupled (and, particularly, the hub of the device and any fitting and associated tubing connected to it) in a stable position relative to the patient, which may entail resisting movement of the device and any associated connector relative to the patient.

[0031] In some embodiments, members 14a, 14b are resilient and/or at least partially rigid. For example, members 14a, 14b may each have a portion (e.g., a portion configured to contact device 5) that is substantially rigid, and another portion configured to resiliently flex (e.g., be deflectable to be coupled to the other members, as described in more detail below). Members 14a and 14b may comprise any suitable material, such as, for example, plastic(s), metal(s), alloy(s), composite(s), or the like, that permits the members to function as described in this disclosure. In other embodiments, members 14a and 14b may have any suitable outer shape, such as, for example, arcuate, curved, square, and/or may be expanded or indented in some portions to improve a user's ability to grip the member and/or the stabilizer.

[0032] In the embodiment shown, members 14a and 14b are substantially identical. As such, only a single member 14a is shown in each of FIGS. 4 and 5. FIG. 6 depicts a perspective view of member 14a without tab 18a. In other embodiments, members 14a and 14b may differ (e.g., may have different connection portions, shapes, and/or the like). In the embodiment shown, member 14a comprises two connection portions 22a and 22b. In the embodiment shown, connection portion 22a is configured as a male connection portion, and connection portion 22b is configured as a female connection portion. Stated another way, in the embodiment shown, male connection portion 22a is configured to be inserted into a corresponding female connection portion 22b of another member (e.g., 14b), and female connection portion 22b is configured to receive a corresponding male connection portion 22a of another member (e.g., 14b).

[0033] In the embodiment shown, male connection portion 22a comprises a resilient barb 26, and the female connection portion comprises a ledge 30 configured such that if members 14a and 14b are coupled together (e.g., with male connection portion 22a of member 14a extending female connection portion 22b of member 14b, and with male connection portion 22a of member 14b extending into female connection portion 22b of member 14a), the resilient barb (26) of each member (14a or 14b) contacts the ledge (30) of the other member (14b or 14a) to resist separation of the members (14a and 14b). In the embodiment shown, barb 26 comprises an arm 34 configured to flex (be deflectable) relative to the rest of member 14a, and a projection 38 (e.g., a tapered projection), such that as members 14a and 14b are pressed together to be coupled, arm 34 of member 14a flexes inward (toward female connection member 22b of member 14a) until projection 38 moves past ledge 30 of member 14b, at which point arm 34 flexes outward such that projection 38 extends past ledge 30 and thereby mechanically resists separation of members 14a and 14b. In other embodiments, connection portions 22a and 22b can have any functional configuration, such as, for example: both connection portions 22a and 22b of member 14a may be configured as male connection portions, and both connection portions 22a and 22b of member 14b may be configured as female connection portions; each of connection portions 22a and 22b may comprise a male component and a female component; each of connection portions 22a and 22b can comprise a serrated or saw-tooth configuration; and/or the like.

[0034] In the embodiment shown, member 14a comprises a coupling surface 42 between connection portions 22a and 22b, and coupling surface 42 is configured such that if the two members are coupled together, the coupling surfaces cooperate to define a device opening 46 in which a portion of an intraosseous device can be positioned (e.g., as shown in FIGS. 1-3). In the embodiment shown, member 14a has a proximal surface 50 (e.g., at or near the plane of tab 18a shown in FIGS. 5-6) configured to face the patient's skin. In the embodiment shown, members 14a and 14b are configured such that if members 14a and 14b are coupled together a longitudinal axis 54 of device opening 46 is disposed at a non-zero angle (e.g., 90 degrees) relative to a plane of proximal surface 50.

[0035] In the embodiment shown, device 5 comprises a hub 58, a flange 62, and a cannula 66 (e.g., a needle may extend through cannula 66 during insertion of cannula into a patient's bone). In some embodiments, coupling surface 42 defines at least one groove 70 configured to receive a flange (e.g., 62) of an intraosseous device. For example, in the embodiment shown, coupling surface 42 defines a plurality of grooves 70a, 70b, 70c, 70d each configured to receive a flange (e.g., 62) of an intraosseous device in a different position of the intraosseous device relative to proximal surface 50 of the member (e.g., if flange 62 is received in groove 70a then flange may be adjacent the patient's skin (or the position the patient's skin would be absent an injury); and if flange 62 is received in any of grooves 70b, 70c, 70d then flange 62 may be spaced apart from a patient's skin at a position predetermined by the position of the groove in which the flange is received. In the embodiment shown, grooves 70a, 70b, 70c, 70d are shaped to correspond to a portion of an intraosseous device (e.g., as shown, grooves 70a, 70b, 70c, 70d are tapered between a relatively larger proximal end closest proximal surface 50 and a relatively smaller distal end that is farther from proximal surface 50).

[0036] As shown, intraosseous device 5 may comprise a fitting 74 (e.g., a Luer lock fitting, or the like) to which a fluid source 78 (a structure from or through which fluid may be delivered to device 5, such as, for example, a tube couplable to an IV bag, and IV bag, a syringe, and/or the like). In the embodiment shown, member 14 has a height or thickness between proximal surface 50 and a distal surface 82 that permits fitting 74 to extend above distal surface 82 to be accessible while stabilizer 10 is coupled to device 5 and/or permits stabilizer 10 to be coupled to device 5 while a fluid source 78 is coupled to device 5. In some embodiments, stabilizer 10 is non-sterile (is not sterile).

[0037] FIGS. 7A-7C depicts various views of member 14a and flexible tab 18a coupled to member 14a (which may together be referred to as a component 100 of stabilizer 10). In the embodiment shown tab 18a is substantially identical to tab 18b. In the embodiment shown, member 14a is configured to be coupled a substantially identical member (e.g., 14b) such that the coupled members (14a and 14b) cooperate to encircle an intraosseous device (e.g., 5) to resist movement of the intraosseous device relative to the members. In some embodiments, member 14a comprises a lower sidewall 104, and one of the one or more flexible tabs (18a) is coupled to lower sidewall 104. For example, in the embodiment shown, tab 18a comprises: a double-sided tape layer 108 having an upper side 112 coupled to a lower surface 116 of lower sidewall 104; and a single-sided tape layer 120 having an adhesive lower side 124 (facing double-sided tape layer 108) coupled to an upper surface 128 of lower sidewall 104 and to a portion of upper side 112 of double-sided tape layer 108 that is not coupled to lower surface 116 of lower sidewall 104. In the embodiment shown, tab 18a also comprises: a liner layer 132 coupled to a lower side (not shown, but facing liner layer 132) of double-sided tape layer 108; and liner layer 132 is configured to be removable from the lower side of double-sided tape layer 108 such that the lower side of the double-sided tape layer can be coupled to skin of a patient. In the embodiment shown, liner layer 132 includes a tab portion 136 that extends beyond at least one peripheral edge of double-sided tape layer 108.

[0038] In some embodiments, at least one lateral dimension (e.g., 140 shown in FIG. 7C) of at least one of the flexible tabs (e.g., 18a), when flattened (nor wrinkled, as shown in FIG. 7C), does not exceed 4 inches. For example, in the embodiment shown, lateral dimension 140, when tab 18a is flattened, does not exceed 3.1 inches.

[0039] FIGS. 8A-8G depict various views of member 14a that may assist in fully understanding the features of member 14a. In particular, FIG. 8A depicts a top view of member 14a; FIGS. 8B-8C depict front and back side views of member 14a; FIGS. 8D-8F depict left and right side views of member 14a; and FIGS. 8F-8G depicts upper perspective views of member 14a. In the embodiment shown, member 14a is configured such that if two members (e.g., 14a, 14b) are coupled together (as shown in FIGS. 1-2), the two coupled members fit within a rectangular volume no greater than 6 inches cubed. For example, in the embodiment shown, member 14a is configured such that if two members (e.g., 14a, 14b) are coupled together, the two coupled members fit within a rectangular volume no greater than 4 inches cubed. The dimensions shown in FIGS. 8A-8G are accurate for at least one embodiment of members 14a.

[0040] Some embodiments of the present kits comprise: three or more of the present members (e.g., 14a) each configured to be coupled to any of the other plurality of members such that the coupled members cooperate to encircle an intraosseous device to resist movement of the intraosseous device relative to the members (e.g., as shown in FIGS. 1-2); and a plurality of flexible tabs (e.g., 18a) each coupled to at least one of the members and comprising an adhesive layer configured to be coupled to skin of a patient.

[0041] Some embodiments of the present methods comprise: coupling one of the present apparatuses (e.g., stabilizer 10) to an intraosseous device (e.g., 5) having a portion (e.g., the cannula) extending into a bone of a patient; and coupling the adhesive layer (e.g., bottom side of double-sided tape layer 108) of at least one of the one or more flexible tabs (e.g., 18a) to the patient such that the apparatus (stabilizer) resists motion of the members (e.g., 14a, 14b) relative to the skin to which the adhesive layer (e.g., 108) is coupled. In some embodiments, coupling the apparatus to the intraosseous device is performed while the intraosseous device is coupled to a fluid source (e.g., 78).

[0042] Some embodiments of the present methods comprise: coupling a support apparatus (e.g., stabilizer 10) to an intraosseous device (e.g., 5) having a portion (e.g., cannula 66) extending into a bone of patient while the intraosseous device is coupled to a fluid source (e.g., 78); and coupling the support apparatus (e.g., 10) to the skin of patient such that the support apparatus resists displacement of the intraosseous device (e.g., 5) relative to the skin to which the support apparatus is coupled.

[0043] The various illustrative embodiments of the present devices and kits are not intended to be limited to the particular forms disclosed. Rather, they include all modifications, equivalents, and alternatives falling within the scope of the claims.

[0044] The claims are not intended to include, and should not be interpreted to include, means-plus- or step-plus-function limitations, unless such a limitation is explicitly recited in a given claim using the phrase(s) means for or step for, respectively.